FDA Adverse Event
Injury
Summary report: N
STEALTHFIX INTRAOSSEOUS FIXATION SYSTEM
MDR report key: 17828334
·
Received September 27, 2023
Report
- Report Number
- 3009540749-2023-00006
- Event Type
- Injury
- Date Received
- September 27, 2023
- Date of Event
- August 25, 2023
- Report Date
- September 27, 2023
- Manufacturer
- MEDARTIS INC.
- Product Code
- JDR
- PMA / PMN Number
- K220181
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
IF ANY INFORMATION IS PROVIDED THAT CHANGES THE OUTCOME OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.
Description of Event or Problem · 0
WHILE USING A THREADED OLIVE WIRE TO HOLD DOWN THE MOST PROXIMAL HOLE IN THE ANTERIOR PLATE, THE OLIVE WIRE BROKE OFF JUST BELOW THE OLIVE, AND COULD NOT BE RETRIEVED. THE THREADED PORTION OF THE OLIVE WIRE WAS LEFT INSIDE THE PATIENT, AND A SCREW WAS PUT IN OFF AXIS TO THE HOLE TO MAKE SURE THEY HAVE FIXATION. THERE WAS A SHORT DELAY BUT THE SURGEON WAS VERY PLEASED WITH THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 316205 | STEALTHFIX INTRAOSSEOUS FIXATION SYSTEM | OLIVE WIRE | JDR | MEDARTIS INC. | 2361336293 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |